Ultra Violette Preen Screen Broad Spectrum SPF 50

Product NDC: 84803-101
11-digit product format: 848030101
Labeler code: 84803
Product ID: 84803-101_533cb134-43ee-e843-e063-6294a90a38a1
Type: HUMAN OTC DRUG
Nonproprietary name: AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Grace and Fire USA Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-12-01
Substance: OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength: 50; 60; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ultra Violette Preen Screen Broad Spectrum SPF 50
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	50 mg/mL
OCTOCRYLENE	60 mg/mL
HOMOSALATE	100 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26a0fc0d-a903-2ac1-e063-6394a90a13db	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84803-101-30	ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit	30 mL in 1 BOTTLE, SPRAY	SPRAY	1 mL in 30	30 mg in 1mL	4
84803-101-30	Ultra Violette Preen Screen Broad Spectrum SPF 50	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2
84803-101-50	Ultra Violette Preen Screen Broad Spectrum SPF 50	50 mL in 1 BOTTLE, SPRAY	SPRAY	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84803-101	ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 (AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [GRACE AND FIRE USA INC.]	1	Current NDC, 2 package rows	20241202_26a0fc0d-a903-2ac1-e063-6394a90a13db.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 286 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bright as Day Mineral SPF50	ZINC OXIDE	Koco Life LLC	1c245a53-4098-62e6-e063-6294a90abf12	2024-09-23	Warnings	Exact identifier application number: M020
Pure Protect Mineral Sunscreen Stick SPF50	ZINC OXIDE	Koco Life LLC	22cd5999-9b9a-91a3-e063-6394a90a0da5	2024-09-23	Warnings	Exact identifier application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen	ZINC OXIDE	Absolutely Natural	eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea	2024-09-23	Warnings	Exact identifier application number: M020
SUNSCREEN 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	229dabbc-9043-3c9d-e063-6394a90a5692	2024-09-21	Warnings	Exact identifier application number: M020
GLC OG Natural Tinted SPF 30 Sunscreen	ZINC OXIDE	GUD LIFE CO. LLC	25e1e8ec-e19d-45f7-b339-5d12c2b511d6	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum	AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE	TARGET CORPORATION	bad7d56e-662e-0776-e053-2a95a90a0af0	2024-09-18	Warnings	Exact identifier application number: M020
Target Up and Up Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	b82b6d0d-616d-f041-e053-2995a90ae6a3	2024-09-18	Warnings	Exact identifier application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	COOLA LLC	43d293f6-e13c-4ee9-89df-2a3ef0034e31	2024-09-16	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protection	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2203ea22-d12a-99fe-e063-6394a90aca9f	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	Allure Labs	22042031-ac8e-1ab2-e063-6394a90a6ed4	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Tinted	ZINC OXIDE	ONESKIN INC.	2204e776-b1a1-be15-e063-6294a90af5de	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	Allure Labs	2205345b-5e92-37eb-e063-6294a90a6b6c	2024-09-13	Warnings	Exact identifier application number: M020
OS-01 Face SPF BS SPF30 Untinted	ZINC OXIDE	ONESKIN INC.	2205ec0e-ac3f-299f-e063-6294a90a2174	2024-09-13	Warnings	Exact identifier application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f4130277-ea9b-6b25-e053-2a95a90a59be	2024-09-13	Warnings	Exact identifier application number: M020
HEB SPF 50 Tattoo Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	f6df491d-1fa9-a4c8-e053-6394a90a3866	2024-09-13	Warnings	Exact identifier application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30	OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE	Skin Ai, LLC	21cbd5ac-5307-939b-e063-6294a90ac791	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu SPF 17	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	Bentley Laboratories LLC	0fd51f8d-ee67-48fd-ab98-1fedb0339462	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu Collagen SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	0246b11b-f1ba-4f47-91ab-52a6554b9467	2024-09-10	Warnings	Exact identifier application number: M020
Mario Badescu The Moisture Magnet SPF 15	AVOBENZONE, OCTINOXATE, OXYBENZONE	Bentley Laboratories LLC	f6d653f5-52a0-42ad-8308-b8d6f57050cc	2024-09-10	Warnings	Exact identifier application number: M020
MARIO BADESCU SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Bentley Laboratories LLC	fe485d4c-0ded-4061-ac34-77b72d535090	2024-09-10	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84803-101-30	84803010130	30 mL in 1 BOTTLE, SPRAY (84803-101-30)	30 ml	2024-12-01	No	No	Current
84803-101-50	84803010150	50 mL in 1 BOTTLE, SPRAY (84803-101-50)	50 ml	2024-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultra Violette Preen Screen Broad Spectrum SPF 50 - Grace and Fire USA Inc.	Grace and Fire USA Inc.	2026-06-01	HUMAN OTC DRUG LABEL	3
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit	Grace And Fire USA Inc.	2026-01-06	HUMAN OTC DRUG LABEL	4
ULTRA VIOLETTE SPF ON THE GLOW - SPF 50 Duo Pack Kit	Thermo-Pak Company, Inc.	2025-11-03	HUMAN OTC DRUG LABEL	1